Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
NCT ID: NCT07045844
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2324 participants
INTERVENTIONAL
2026-02-01
2030-07-31
Brief Summary
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Does supplementing OMM with pHDM or PTF improve survival without surgery-requiring necrotizing enterocolitis (NEC) by 34 weeks corrected gestational age? Is routine fortification of human milk better than selective fortification based on growth faltering?
Researchers will compare:
pHDM vs. PTF to see which better supports survival without severe NEC. Routine fortification vs. selective fortification to assess the impact on growth and long-term neurodevelopment.
Participants will:
Be randomized twice:
* First, within the first week of life to receive either pHDM or PTF when OMM is insufficient
* Second, in the second week of life to receive either routine fortification or selective fortification only if growth faltering occurs Receive feeding and care as per standard clinical practice Complete neurodevelopmental assessment at 2 years corrected age using the PARCA-R tool (no additional study visits required) This multicenter, double-randomized, open-label randomized controlled trial is embedded in routine neonatal care and uses real-world data to assess both short- and long-term outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pasteurized Donor Milk for Insufficient Breastfeeding
Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Pasteurized Donor Milk for Insufficient Breastfeeding
Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.
Routine fortification
Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \[OMM\] and/or donor pasteurized human milk \[pHDM\] ) reaches between 60-120 mL/kg
Rescue fortification
Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consistently below 1.5 mmol/L, and there are no severe complications such as active sepsis or the need for vasoactive medications to maintain circulatory stability. Chronic sodium depletion has also been ruled out, as this condition alone can lead to growth failure. Additionally, preterm infants are unable to tolerate high-volume feeding of 180 mL/kg/day due to specific reasons, such as severe gastroesophageal reflux or the presence of a high-output stoma following surgical procedures).
Preterm formula for Insufficient Breastfeeding
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Preterm Formula for Insufficient Breastfeeding
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.
Routine fortification
Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \[OMM\] and/or donor pasteurized human milk \[pHDM\] ) reaches between 60-120 mL/kg
Rescue fortification
Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consistently below 1.5 mmol/L, and there are no severe complications such as active sepsis or the need for vasoactive medications to maintain circulatory stability. Chronic sodium depletion has also been ruled out, as this condition alone can lead to growth failure. Additionally, preterm infants are unable to tolerate high-volume feeding of 180 mL/kg/day due to specific reasons, such as severe gastroesophageal reflux or the presence of a high-output stoma following surgical procedures).
Interventions
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Pasteurized Donor Milk for Insufficient Breastfeeding
Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.
Preterm Formula for Insufficient Breastfeeding
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.
Routine fortification
Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \[OMM\] and/or donor pasteurized human milk \[pHDM\] ) reaches between 60-120 mL/kg
Rescue fortification
Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consistently below 1.5 mmol/L, and there are no severe complications such as active sepsis or the need for vasoactive medications to maintain circulatory stability. Chronic sodium depletion has also been ruled out, as this condition alone can lead to growth failure. Additionally, preterm infants are unable to tolerate high-volume feeding of 180 mL/kg/day due to specific reasons, such as severe gastroesophageal reflux or the presence of a high-output stoma following surgical procedures).
Eligibility Criteria
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Inclusion Criteria
* No contraindications to enteral feeding;
* Mother is willing to breastfeed.
Exclusion Criteria
* For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;
1 Day
14 Days
ALL
No
Sponsors
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Imperial College London
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Responsible Party
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Yanping Xu
Dr.
Locations
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Yongkang Maternity and Child Health Care Hospital
Guli, Zhejiang, China
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Hangzhou Women's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing Maternity and Child Health Care Hospital
Jiaxing, Zhejiang, China
Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University)
Ningbo, Zhejiang, China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine)
Yiwu, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2025-IRB-0232-P-02
Identifier Type: -
Identifier Source: org_study_id
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